ComplianceOnline

Course "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities..

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing of this course, participants should be able to:

  • Understand the FDA and EMEA’s requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes:
    • Develop a high-level PV audit strategy
    • Identify the PV activities and processes subject to PV audit
    • Develop risk assessment criteria
    • Identify the PV audit universe – entities subject to PV audit
    • Categorize the entities subject to PV audit
    • Perform risk assessments
    • Prioritize entities for audit according to relative risk
    • Prepare a 3-5 year PV audit plan
  • Identify procedures/tools to monitor PV quality of third parties

Who will Benefit:

This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities.

The following personnel will benefit from the course:

  • PV Quality Assurance Staff
  • PV Compliance professionals
  • Quality auditors
  • Pharmacovigilance Auditors
  • Relevant Pharmacovigilance Staff
  • PV Service Provider Relationship Managers
  • MAH Affiliates responsible for Pharmacovigilance
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There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.

Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Review of FDA and EMEA requirements for risk based PV audits
  • The pharmacovigilance system and the quality system
  • Strategic level audit planning
  • Hands on exercise
  • PV activities and processes subject to PV audit
  • Risk assessment criteria
  • The PV audit universe - all entities subject to PV audit
  • Safety data exchange agreements (SDEAs) and vendor contracts
Day 02(8:30 AM - 4:30 PM)
  • Stability (shelf-life) studies
  • Categorization of the entities (PV Audit Universe)
  • Risk assessments
  • Prioritization of entities for audit according to relative risk
  • 3-5 year PV audit plan
  • Hands on exercise
  • Procedural documents, e.g. SOPs
  • Identify procedures/tools to monitor PV quality for oversight of third parties
  • Q & A
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Michelleanne Bradley

Michelleanne Bradley
Drug Safety and Pharmacovigilance Consultant, Edge Alliance, LLC

Michelleanne Bradley has worked in Drug Safety and Pharmacovigilance in a variety of roles. She has been the “Pharmacovigiliance department of one” with three organizations and counting. Her specialty is consulting with small companies as they start Drug Safety/Pharmacovigilance departments. Michelleanne has also worked for small, medium, and large biotech and pharmaceutical organizations, performed audits, advised on audit-readiness activities, written SOPs, and installed databases. She consults for Edge Alliance, and is the President of Metis Consulting Services Inc.

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$1,499.00

Seminar One Registration

November 9-10, 2017, San Francisco, CA
(For Registrations till August 5, 2017 - $1499)
(For Registrations till September 5, 2017 - $1699)
(For Registrations till October 15, 2017 - $1899)
(For Registrations after October 15, 2017 - $2099)

$2,199.00

Seminar One Registration (With 2 Nights Stay)

November 9-10, 2017, San Francisco, CA

$6,799.00
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November 9-10, 2017, San Francisco, CA
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Your registration fee includes the workshop, all course materials and lunch.


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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Location:

San Francisco, CA
(Venue to be announced shortly)

November 9-10, 2017

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